Document Number
CAPA-003
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Regulatory Affairs
Owner
Regulatory Affairs
ISO Clause
FDA MDR, EU MDR
Tier Level
Tier 2 — SOP/Plan
FDA MDR and EU MDR vigilance reporting for serious adverse events and field safety corrective actions.
#adverse-event#mdr#vigilance#fda#eumdr
Approval Status
DraftEffective: May 7, 2026
Regulatory Standards
ISO 13485:201621 CFR Part 820EU MDR 2017/745
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Regulatory Affairs | Initial release |